Zoryve FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 9, 2023.
FDA Approved: Yes (First approved July 29, 2022)
Brand name: Zoryve
Generic name: roflumilast
Dosage form: Cream
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis
Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the topical treatment of plaque psoriasis.
- Zoryve is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
- Zoryve contains roflumilast which is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4). PDE4 is an intracellular enzyme that drives overactive immune responses in a range of inflammatory diseases including psoriasis, eczema, and COPD.
- Roflumilast was first approved by the U.S. Food and Drug Administration (FDA) in 2011 as an oral formulation under the brand name Daliresp, which is used to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD).
- Zoryve is approved for the treatment of mild, moderate, and severe plaque psoriasis with no limitations on duration of use.
- Zoryve cream is applied to the affected areas once daily.
- Common adverse reactions include diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections
Development timeline for Zoryve
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